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Quadrant Total Etch is used in the dental adhesive restorative technique for conditioning of enamel and dentin following the so-called "total etch technique", prior to the use of a bonding agent such as Quadrant UniBond. .

With this technique, numerous sites for mechanical retention on micro-scale will be created, forming an excellent basis for the bonding agent to penetrate, seal off the enamel and dentin surface and bond the composite restorative material to the cavity wall.

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I am sorry, but the provided text from the FDA document (K984043) does not contain information on the acceptance criteria, study details, or performance metrics for the Quadrant Total Etch device.

The document is a 510(k) clearance letter, which states that the device is "substantially equivalent" to previously marketed devices. It confirms that the manufacturer can market the product subject to general controls and regulations. It also specifies the indications for use.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report, which would typically describe the testing performed and its results.

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